Tagged Articles

serious adverse health consequences 29 articles

Injuries, death linked to recalled NaturaLyte dialysis concentrate

Fresenius Medical Care, the world’s largest provider of dialysis products and services, has received one report of death and two injuries linked to recalled lots of NaturaLyte liquid bicarbonate concentrate. The recall was initiated after testing revealed that certain lots of NaturaLyte had elevated levels of a bacteria identified as Halmonas, a Gram Negative bacteria typically found in water with high salinity. Bacterial contamination of dialysate could cause bacteremia or systemic infection. Fresenius issued a recall of 49 lots in on April 4, followed by a second recall of nine additional lots on May 1. At that time, Fresenius said that ... Read More

City of Chicago files lawsuit accusing drug companies of deceptively marketing addictive painkillers

In the latest battle against prescription drug abuse, the City of Chicago has filed a lawsuit against five drug companies alleging they engaged in deceptive marketing practices for their highly addictive painkillers to reel in extra profit. The lawsuit, filed this week in Cook County Circuit Court, claims the pharmaceutical companies pushed long-term use of their powerful opioids to treat non-cancer pain, which was false, misleading and “unsupported by science.” The lawsuit comes just one month after two California counties filed a similar lawsuit against the same five drug companies – Johnson & Johnson’s Janssen Pharmaceuticals, Purdue Pharma, Actavis, Endo ... Read More

Hospira recalls infusion pump docking stations due to defect that may cause life threatening delay in therapy

Hospira Inc., is initiating a nationwide recall of the GemStarDocking Station, used in conjunction with the GemStar infusion pump, due to a defect that could lead to a delay in therapy, which could cause serious health consequences including death. Infusion pumps are used to deliver medicine and nutrients to patients in a controlled manner. The recall affects the GemStar Docking Station with the list number 13075. When the device is used in conjunction with a GemStar Phase 3 pump (List 13000, 13100 or 13150) the potential exists for the GemStar Phase 3 pump to fail to power up while connected to ... Read More

Abbott, Hospira infusion pumps recalled due to defect that may result in over-infusion, delay in therapy

Abbott Acclaim and Hospira Acclaim Encore Infusion Pumps used to deliver fluids such as medicine and nutrients into a patient’s body in a controlled manner are being recalled due to reports that the doors on the machines do not close. This can cause an over-infusion or a delay in therapy, both of which can cause serious adverse health consequences, including death. Hospira received reports of broken door assemblies on the Abbott Acclaim and Hospira Acclaim Encore Infusion Pumps. When the door is closed properly, it helps ensure that the tubing is seated properly to ensure appropriate flow of therapy to ... Read More

FDA shuts down cheese factory linked to deadly listeria outbreak

The Food and Drug Administration (FDA) has shut down production at a Delaware cheese factory linked to a deadly listeria outbreak after an inspection revealed numerous unsanitary conditions that the agency said created a “reasonable probability” that cheese produced there could cause “serious adverse health consequences or death to humans.” Roos Foods Inc., recalled 16 varieties of Hispanic-style cheeses last month after reports of one death in California and seven illnesses in Maryland from listeria infections. Those sickened included mothers and newborn babies. The recall involved all of Roos Foods’ Mexicana, Amigo, Santa Rosa De Lima and Anita brands, which ... Read More

Ventilators recalled due to software problems that could render the devices useless

Covidien is recalling its Puritan Bennett 840 Series Ventilators because the devices have a software problem that causes the ventilator to stop functioning, triggering the safety alarm and causing the patient to “suddenly be required to breathe on his own,” according to a Food and Drug Administration (FDA) safety announcement. Ventilators are devices used on critically ill people who may not be able to continue breathing on their own. Thus, this software malfunction can cause patients to suffer serious adverse health consequences, including death. The recall includes software Part Number 4-070212-85, Revision AB-AG, and was manufactured April 30, 1998 to ... Read More

FDA warns that nipple aspirate tests should not be stand-alone tool for breast cancer diagnosis

Nipple aspirate tests to detect abnormal cells in the breast should not be used in place of mammograms, other breast imaging tests, or biopsy as a tool to screen for or diagnose breast cancer, the Food and Drug Administration (FDA) said in a safety advisory. A nipple aspirate test uses a type of pump device to collect fluid from a woman’s breast. It can determine whether the fluid contains abnormal cells. The agency warned that there is no valid scientific data to show that the nipple aspirate test by itself is an effective screening tool for any medical condition including the ... Read More

Edwards Lifesciences recalls catheter used in heart bypass surgery

Edwards Lifesciences is recalling its EMBOL-X Glide Protection System due to a defect in the catheter tip that if used may cause serious or deadly complications. The EMBOL-X Glide is a device used to help capture material such as blood clots or tissue fragments during short-term cardiopulmonary bypass surgery when surgeons may need to introduce and remove devices into the vascular system. This recall is listed as a Class 1, which is the most serious type of recall and involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or ... Read More

Fresenius to open dialysis clinic in McCalla, Ala.

Fresenius Medical Care, the world’s largest provider of dialysis services and products, will open a dialysis clinic in McCalla, Ala. The facility is expected to be be in operation by May or June 2014. The property, located near McAdory High School, was purchased by Southeast Medical McCalla LLC. Construction on a one-story medical office building is expected to start sometime in October. Fresenius operates dialysis clinics throughout the country and provides dialysis products, such as dialysis concentrates GranuFlo and NaturaLyte, for both Fresenius-owned and non-Fresenius clinics. The company is facing numerous wrongful death, personal injury and false advertising lawsuits involving ... Read More

DePuy recalls defective femur bone implant

DePuy Othopaedices, a subsidiary of Johnson & Johnson, is recalling an implant used to replace part or all of the femur bone. The device could fracture when exposed to normal weight loads while walking, which can cause pain, infection, loss of limb, neurovascular injury or the need for revision surgery. Patients heavier than 200 pounds and those who are highly active are at greater risk for fracture. DePuy has notified doctors and hospitals of the defect with the LPS Lower Extremity Dovetail Intercalary component. The medical device company is also providing surgeons with a patient letter template for notifying their ... Read More